In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a calcium resonium Drug Master File in Korea (calcium resonium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of calcium resonium. The MFDS reviews the calcium resonium KDMF as part of the drug registration process and uses the information provided in the calcium resonium KDMF to evaluate the safety and efficacy of the drug.
After submitting a calcium resonium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their calcium resonium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of calcium resonium suppliers with KDMF on PharmaCompass.